BACLOFEN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BACLOFEN (UNII: H789N3FKE8) (BACLOFEN - UNII:H789N3FKE8)

Available from:

Marlex Pharmaceuticals Inc

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Baclofen is useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions. Hypersensitivity to baclofen.

Product summary:

Baclofen Tablets, USP, 10 mg are available as a white round flat-faced beveled edge bisected tablet debossed with “LCI” over “1330” on one side and plain on the other side, containing 10 mg Baclofen USP. Available in bottles of 100 (NDC 10135-0532-01), 500 (NDC 10135-0532-05) and 1000 (NDC 10135-0532-10). Baclofen Tablets, USP, 20 mg are available as a white round flat-faced beveled edge bisected tablet debossed with “LCI” over “1337” on one side and plain on the other side, containing 20 mg Baclofen USP. Available in bottles of 100 (NDC 10135-0533-01), 500 (NDC 10135-0533-05), 1000 (NDC 10135-0533-10) PHARMACIST: Dispense in a well-closed container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured by: Lannett Company, Inc. Philadelphia, PA 19136 Distributed By: Marlex Pharmaceuticals, Inc. New Castle, DE 19720 Made in the USA Rev.1 5/20 LAN 

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BACLOFEN- BACLOFEN TABLET
MARLEX PHARMACEUTICALS INC
----------
BACLOFEN
BACLOFEN TABLETS, USP
RX ONLY
DESCRIPTION
Baclofen USP is a muscle relaxant and antispastic.
Its chemical name is 4-amino-3-(-4-chlorophenyl)-butanoic acid. The
structural formula
is:
Baclofen USP is a white to off-white, odorless or practically odorless
crystalline powder.
It is slightly soluble in water, very slightly soluble in methanol and
insoluble in chloroform.
Each tablet, for oral administration, contains 10 mg or 20 mg
baclofen. In addition, each
tablet contains the following inactive ingredients: microcrystalline
cellulose, pregelatinized
starch, colloidal silicon dioxide, and magnesium stearate.
CLINICAL PHARMACOLOGY
The precise mechanism of action of baclofen is not fully known.
Baclofen is capable of
inhibiting both monosynaptic and polysynaptic reflexes at the spinal
level, possibly by
hyperpolarization of afferent terminals, although actions at
supraspinal sites may also
occur and contribute to its clinical effect. Although baclofen is an
analog of the putative
inhibitory neurotransmitter gamma-aminobutyric acid (GABA), there is
no conclusive
evidence that actions on GABA systems are involved in the production
of its clinical
effects. In studies with animals baclofen has been shown to have
general CNS
depressant properties as indicated by the production of sedation with
tolerance,
somnolence, ataxia, and respiratory and cardiovascular depression.
Baclofen is rapidly
and extensively absorbed and eliminated. Absorption may be
dose-dependent, being
reduced with increasing doses. Baclofen is excreted primarily by the
kidney in
unchanged form and there is relatively large intersubject variation in
absorption and/or
elimination.
INDICATIONS AND USAGE
Baclofen is useful for the alleviation of signs and symptoms of
spasticity resulting from
multiple sclerosis, particularly for the relief of flexor spasms and
concomitant pain,
clonus, and muscular rigidity.
Patients should have reversible spasticity so that baclofen treatment
will aid